Novartis’ MS drug hits primary PhIII target

Novartis' experimental multiple sclerosis drug siponimod has hit its key target in a late-stage trial, raising hopes for a new treatment option for patients.

Data from the Phase III EXPAND trial, which assessed the efficacy and safety the oral once-daily drug in secondary progressive multiple sclerosis (SPMS), met its primary endpoint of reducing the risk of disability progression compared with placebo. Information on secondary targets has not been disclosed at this time.

"SPMS is a particularly disabling form of MS, and there is a need for effective treatment options to help delay disability progression in those living with the condition," said Vasant Narasimhan, Novartis' chief medical officer. "The positive EXPAND data are encouraging for a disease with such a high unmet need".

Most people with relapsing remitting forms of MS will eventually go on to develop SPMS; on average, around 65 percent will develop SPMS 15 years after being diagnosed, according to the MS Society.

Siponimod is a selective modulator of specific types of the sphingosine-1-phosphate (S1P) receptor, which is commonly found on the surface of specific cells in the central nervous system that are responsible for causing damage that drives loss of function in SPMS.

The drug enters the brain binding to these specific receptors, which may prevent the activation of these harmful cells, helping to reduce loss of physical and cognitive function associated with SPMS, the firm said.

Novartis will now complete a full analyses of the data and "evaluate next steps in consultation with health authorities", and also plans to share top-line data at the ECTRIMS congress in London next month.